AXSOS 705031SRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07613327083330), received between Aug 8, 2016 and May 19, 2026 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Fracture

  THE CUSTOMER REPORTED THE FOLLOWING: "THE 3.1-MM DRILL BIT GETS STUCK IN THE SOCKET DURING DRILLING FOR NO APPARENT REASON. DRILL BIT REPLACEMENT: A NEW DRILL BIT IS USED BUT BREAKS OFF INSIDE THE PATIENT. UNABLE TO REMOVE IT: IT REMAINS IN THE LEG BONE. NO CLINICAL CONSEQUENCES AT THIS TIME."

  Patient problems: Foreign Body In Patient

  MAUDE report 25217661 ↗
• MalfunctionJan 9, 2026Mechanical Jam

  AS REPORTED: "FOLLOWING DRILLING, THE DRILL SLEEVE AND DRILL BECAME STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DRILL AND SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028748 ↗
• InjuryJan 7, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED, ORIF WAS PERFORMED FOR A PATIENT WITH RIGHT TIBIA FRACTURE. DRILL WAS FRACTURED DURING USE, AND TIP OF IT WAS LEFT IN THE BONE. THUS, THE SURGEON MADE AN ADDITIONAL INCISION AND REMOVED IT FROM THE BONE ON THE OPPOSITE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 21095548 ↗
• MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE DRILL STUCK IN DRILL GUIDE WHILE DRILLING. IT IS NOT REMOVABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924910 ↗
• MalfunctionApr 18, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "WHEN DRILLING THROUGH THE LOCKING SLEEVE, AFTER DRILLING THE FRONT CORTEX, A STRANGE SOUND WAS HEARD AND THE DRILL COULD NOT BE PULLED OUT. WHEN THE ENTIRE SLEEVE WAS PULLED OUT, THE DRILL CAME OUT WITH IT, BUT THE DRILL COULD NOT BE PULLED OUT OF THE SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766113 ↗
• MalfunctionSep 29, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "DRILL STUCK IN SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502344 ↗
• MalfunctionAug 23, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A DRILL BIT BROKE AND THE DRILL TIP REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15275911 ↗
• MalfunctionJun 29, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "WHEN DRILLING, A DRILL BIT GOT STUCK IN THE MIDDLE OF A DRILL SLEEVE AND COULD NEITHER BE ADVANCED NOR REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852149 ↗
• MalfunctionMar 16, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING AXSOS SURGERY, AFTER USING OSFERION FOR A PROXIMAL TIBIA FRACTURE, THE SLEEVE AND DRILL GOT STUCK WHEN DRILLING WITH A ROCKING DRILL. SPARE DRILL WAS USED AND THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789847 ↗
• MalfunctionMar 15, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT DRILL BROKE OFF IN PATIENT AND WAS LEFT IN SITU.

  Patient problems: Foreign Body In Patient

  MAUDE report 13776696 ↗
• MalfunctionDec 1, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED: "AXSOS-DT (ANTERIOR LATERAL) IS BEING USED FOR TIBIAL PILON FRACTURE. DURING THE FIRST FIRST DISTAL LOCKING DRILL, THE DRILL AND SLEEVE GOT STUCK . IT WAS TURNED IT TO PUSH THE DRILL FORWARD, BUT IT STUCK AND DID NOT PROCEED. ATTEMPTED TO REMOVE THE DRILL ONCE, BUT IT DID NOT ROTATE IN THE FORWARD ROTATION, SO WHEN TRIED TO REMOVE IT BY ROTATING IN THE REVERSE DIRECTION, THE SLEEVE ALSO ROTATED IN THE REVERSE DIRECTION AND CAME OFF THE PLATE. GRABBED THE SLEEVE WITH PLIERS AND SLOWLY ROTATED THE DRILL TO TRY TO PULL IT OUT, BUT IT DIDN'T COME OFF AT ALL. HE DECIDED THAT HE COULDN'T USE IT, SO HE OPENED ANOTHER NEW ONE AND CONTINUED THE OPERATION WITH ANOTHER SLEEVE. STILL THE SAME THING HAPPENED. HOWEVER, THIS TIME, PULLED IT OUT IMMEDIATELY, GRASPED THE SLEEVE WITH PLIERS, AND SLOWLY TURNED THE DRILL TO PULL IT OUT. IN THE SURGICAL FIELD, THE SLEEVE WAS DRILLED SEVERAL TIMES TO CONFIRM, AND THE OPERATION WAS CONTINUED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907050 ↗
• MalfunctionNov 3, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE USING A PROXIMAL ROCKING DRILL, THE DRILL BIT BECAME STUCK IN THE SLEEVE AND COULD NOT BE INSERTED OR REMOVED ANY FURTHER. THE POWER TOOL WAS REPLACED WITH A HAND-CRANKED HANDLE, AND THE DRILL WAS REMOVED FROM THE SLEEVE BY REVERSE ROTATION. AFTER THAT, ANOTHER SLEEVE WAS CONNECTED TO THE PLATE, A NEW DRILL BIT WAS USED, AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745109 ↗
• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN USING A STERILIZED DRILL THROUGH A SLEEVE, THE SLEEVE AND DRILL GOT STUCK. THE SURGEON OPENED THE SPARE DRILL TIP AND USED IT WITH ANOTHER SLEEVE, BUT THE SAME EVENT OCCURRED IN OTHER HOLE. AFTER THAT, THE SURGERY WAS COMPLETED USING A 3MM K WIRE AS A SUBSTITUTE AND A TAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280416 ↗
• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN USING A STERILIZED DRILL THROUGH A SLEEVE, THE SLEEVE AND DRILL GOT STUCK. THE SURGEON OPENED THE SPARE DRILL TIP AND USED IT WITH ANOTHER SLEEVE, BUT THE SAME EVENT OCCURRED IN OTHER HOLE. AFTER THAT, THE SURGERY WAS COMPLETED USING A 3MM K WIRE AS A SUBSTITUTE AND A TAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280312 ↗
• MalfunctionJul 29, 2021Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam

  AS REPORTED: "THE DRILL AND SLEEVE STUCK DURING DRILLING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246209 ↗
• MalfunctionJul 27, 2021Mechanical Jam; Mechanical Jam

  THE FOLLOWING WAS REPORTED: AFTER TEMPORARILY FIXING THE PLATE WITH K WIRE, ONE CORTICAL SCREW WAS INSERTED TO THE DISTAL HOLE. AFTER THAT, WHEN THE SURGEON DRILLED TO INSERT THE LOCKING SCREW TO THE ANTERIOR PROXIMAL SCREW HOLE, THE DRILL HAS STOPPED WORKING INSIDE THE DRILL SLEEVE. THE DRILL DID NOT BE REMOVED BY ANY MEANS. FINALLY, THE SURGEON REMOVED THE SLEEVE AND DRILL TOGETHER WITH THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235522 ↗
• MalfunctionJun 25, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING SURGERY, THE DRILL STUCK TO THE DRILL SLEEVE. ONCE THE SURGEON TOOK IT OUT OF THE PATIENT WITH THE SLEEVE, THE DRILL WAS BITING INTO THE SLEEVE. AFTER THAT, OTHER INSTRUMENTS WERE USED AND THE SURGERY WAS FINISHED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071598 ↗
• MalfunctionJan 5, 2021Device Damaged by Another Device; Mechanical Jam; Device Damaged by Another Device; Mechanical Jam

  AS REPORTED: " THE DRILL BIT WAS CRIMPED TO THE DRILL SLEEVE DURING USE AND COULD NOT BE REMOVED. THE DRILL BIT WAS NEW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121368 ↗
• MalfunctionDec 21, 2020Mechanical Jam; Mechanical Jam

  AS REPORTED: "DRILLING IS PERFORMED USING A DRILL SLEEVE SHORT. AFTER DRILLING, THE DRILL DID NOT COME OUT OF THE SLEEVE. DOCTOR'S OPINION: IT IS POSSIBLE THAT THE INSIDE OF THE SLEEVE WAS DRILLED AND SCRAPED FOR SOME REASON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11051686 ↗
• MalfunctionJun 8, 2020Overheating of Device; Smoking; Noise, Audible; Difficult or Delayed Separation; Overheating of Device; Smoking; Noise, Audible; Difficult or Delayed Separation

  AS REPORTED: "WHEN I WAS USING THE 3.1 DRILL FOR THE AXSOS LOCKING SCREW, THERE WAS A STRANGE NOISE, HEAT, AND SMOKE. I TRIED TO REMOVE THE LOCKING SLEEVE, BUT IT WAS STUCK WITH THE TIP OF THE DRILL AND DID NOT COME OFF." ADDITIONALLY REPORTED: "SALINE WAS APPLIED TO COOL THE HEAT-GENERATING PART. REPLACED WITH ANOTHER DRILL TIP AND SLEEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10131111 ↗
• MalfunctionDec 26, 2019Break; Break

  DURING ORIF PROCEDURE, DRILL BIT WAS USED TO MAKE A DISTAL HOLE. THEN WHEN A SCREW WAS ATTEMPTED TO INSERT, IT COULD NOT BE INSERTED NORMALLY, EVEN THOUGH REINSERTION OF THE SCREW WAS ATTEMPTED FOR A FEW TIMES. THE NURSE POINTED OUT THAT IT COULD BE POSSIBLE THAT THE TIP OF THE DRILL WAS BROKEN (MISSING A PART). THE SURGEON¿S OPINION: THE PATIENT HAD THICK CORTEX, THIS COULD BE A REASON THAT THE SCREW COULD NOT BE INSERTED WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521815 ↗
• MalfunctionSep 20, 2019Fracture

  THE CUSTOMER REPORTED THAT THE PATIENT WAS UNDERGOING FIXATION OF TIBIAL PLATEAU FRACTURE. WHILE DRILLING THE DRILL BIT FRACTURED AND APPROXIMATELY 2CM (NEARLY ALL OF THE FLUTED SECTION REMAINED IN THE BONE. A DECISION WAS TAKEN TO LEAVE THE DRILL BIT FRAGMENT IN SITU.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9099822 ↗
• MalfunctionSep 16, 2019Material Puncture/Hole; Packaging Problem; Packaging Problem

  AS REPORTED: "THE STERILE DRILL PACK WAS CAREFULLY OPENED AND THE SCRUB NURSE PICKED UP THE OPPOSITE END AND WENT TO OPEN WHEN HE NOTICED THE WAS A HOLE IN THE STERILE PAPER LID. THE EXTERNAL PACKAGING WASN'T DAMAGED SO THE DRILL WAS STILL DEEMED STERILE." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH "SLIGHT SURGICAL DELAY" AND NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9073051 ↗
• InjuryJul 17, 2019Entrapment of Device

  DURING AXSOS DT SURGERY, THE DRILL BIT STUCK INSIDE THE DRILL SLEEVE AFTER THE DRILLING. THE SURGEON REMOVED THE DRILL BIT FROM THE SLEEVE BY FORCE, SOFT TISSUE HAD BEEN ENTANGLED TO THE DRILL. WHEN THE SURGEON REMOVED THE DRILL BIT FROM THE SLEEVE, THE PATIENT BONE SCRAPED A LITTLE EXTRA. AFTER THAT THE PROCEDURE CONTINUED WITHOUT PROBLEM.

  Patient problems: No Code Available

  MAUDE report 8799477 ↗
• InjuryJun 25, 2019Break

  IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN DURING FIXATION OF TIBIA FRACTURE. THEREFORE, ADDITIONAL SKIN INCISIONS WERE MADE AND BROKEN PIECE REMOVED WITH CROWN REAMER AND LUER BONE RONGEURS. AFTER THAT, DRILLING WITH NEW DRILL BIT AND THE OPERATION WAS FINISHED.

  Patient problems: No Code Available

  MAUDE report 8732818 ↗